Submission on Application A589 Food derived from LLRICE rice: to permit the use in food of rice genetically modified to be tolerant of the herbicide glufosinate ammonium (Bayer Crop Science Pty Ltd)

PSRG urges Food Standards Australia New Zealand to reject the above application. Rice products are likely to be supplied to markets in New Zealand and New Zealanders have the right to expect regulatory authorities to adopt a cautious approach to food safety and health considerations. On the grounds of human health and safety, PSRG believes that acceptance of this application is not warranted.

Considerations:

Toxicity and allergenicity of GE foods

Research consistent with the WHO published protocols (1) has not been carried out on the effect of any novel proteins on humans, the intended consumers of this rice. The novel proteins are very likely to arise both as a result of the DNA insertion event/s and also as a result of the increased amount of the new transgenic foreign protein inserted into the cell. To assume that the increase in this foreign protein and the DNA insertion process will not result in considerable changes to the levels of primary or secondary metabolites in the cell shows little regard for food safety. Food allergies to any new proteins are a very important food safety issue and should be tested for such on an on-going basis. Not only can people and animals become allergic to foreign proteins, they can also develop new cross allergies to other unrelated foods because they have become sensitised. This has occurred with mice fed on GE peas (Fabaceae family), genetically engineered with a protein derived from the closely related bean, also in the Fabaceae family (2).

There is little if any published work on GE rice feeding studies, but one needs only to look at the research on GE soy to see that allergies are a serious health issue. Soy allergies jumped 50% in the UK just after GE soy was introduced (3). If GE soy was the cause, it may be due to several things. The GE protein that makes Roundup Ready Soy resistant to the herbicide does not have a history of safe use in humans and may be an allergen. In fact, sections of its amino acid sequence are identical to known allergens (4).

A portion of the transgene from ingested GE soybeans, along with the promoter that switches it on, transfers into human gut bacteria during ingestion (5). The fact that transformed bacteria survive applications of Roundup’s active ingredient, glyphosate, suggests that the transgene continues to produce the Roundup Ready protein. If true, then long after people stop eating GE soy they may be constantly exposed to its potentially allergenic protein, which is being created within their gut. (This protein may be made more allergenic due to misfolding, attached molecular chains, or rearrangement of unstable transgenes, but there is currently insufficient data to support or rule out these possibilities.)

Studies suggest that the GE transformation process may have increased natural allergens in soybeans. The level of one known allergen, trypsin inhibitor, was 27% higher in raw GE soy varieties. More worrisome, it was as much as sevenfold higher in cooked GE soy compared to cooked non-GE soy (6). Not only is this higher amount potentially harmful, the finding also suggests that the trypsin inhibitor in GE soy might be more heat stable and, therefore, even more allergenic than the natural variety (7).

It is also possible that changes in GE soy DNA may produce new allergens. Although there has never been an exhaustive analysis of the proteins or natural products in GE soy, unpredicted changes in the DNA were discovered. A mutated section of soy DNA was found near the transgene, which may contribute to some unpredicted effects. Moreover, between this scrambled DNA and the transgene is an extra transgene fragment, not discovered until years after soy was on the market (8). The RNA produced is completely unexpected. It combines material from all three sections: the full-length transgene, the transgene fragment, and the mutated DNA sequence. This RNA is then further processed into four different variations (9), which might lead to the production of some unknown allergen.

Another study verified that GE soybeans contain an IgE-binding allergenic protein not found in non-GE soy controls, and that one of eight subjects who showed a skin-prick allergic reaction to GE soy had no reaction to non-GE soy (10). Although the sample size is small, the implication that certain people react only to GE soy is huge.

Mice fed GE soy had reduced levels of pancreatic enzymes (11,12). When protein-digesting enzymes are suppressed proteins may last longer in the gut, allowing more time for an allergic reaction to take place. Any reduction in protein digestion could therefore promote allergic reactions to a wide range of proteins, not just to the GE soy.

Allergies to GE foods have already been widely recorded in the US, where thousands of consumers complained to food manufacturers about possible reactions to StarLink corn (13, 14).A paper just published documents experimental work showing that minute quantities of a bacterial protein inserted into GE corn provoke immune reactions in mice (15). The protein was added to increase the effectiveness of plant-based transgenic vaccines. Eating extremely small amounts of LT-B several times over less than a month caused exposed mice to develop immune reactions to the protein. Cumulative consumption of GE rice in processed foods

Rice products are widely used in the production of processed foods, particularly for those who are intolerant or sensitive to gluten. The rice products could therefore be widely consumed on a daily basis in multiple food products.

Molecular characterization of the transgenic insert

The FSANZ safety assessment assumes that the molecular characterization of the transgenic insert has been carried out. This assumes that the transgene will stay put and be completely stable. The lack of stability of transgenic inserts is of major concern to scientists, particularly with respect to viral promoters (CaMV 35S) switching on dormant viruses and possibly oncogenes.

The molecular characterization is incomplete. The data presented does not definitively exclude the possibility that LLRICE62 contains additional novel genes, derived either from the expression of fragments of inserted DNA or novel fusion proteins created at the junctions of inserted DNA and the rice genome.

Professor David Williams, a New Zealander carrying out medical genetic engineering research at the San Diego School of Medicine, California, has said the following on transgenics (January 2004):

“I’m afraid that most of us who work with transgenics are pretty uncritical. Most of us assay for the transgenic product and ignore the secondary effects. Even those people doing functional genomics on transgenics mostly ignore changes that ‘don’t make sense’, i.e., cannot be seen as immediately attributable to the transgene. Hence, it’s hard to get an idea of the extent and prevalence of downstream effects from insertional mutagenesis and simple imbalances caused by transgene expression. The biggest risk is that we don’t know. The problem with transgenics that are released into the environment and used in the food supply, however, is that the potential consequences of deleterious unknowns are clearly greater.”

Toxic effects of glufosinate ammonium

Toxicity of glufosinate ammonium residues is likely because plants are tolerant to high doses and repeated sprayings. It is likely that the GE rice has been top-dressed rather than row-sprayed with glufosinate ammonium. This is certainly the case with RoundupReady soybeans in Argentina and other parts of America (16).

Glufosinate ammonium is a phosphinic analogue of glutamic acid. Its activity is related to the inhibition of glutamine synthetase. A 1995 study has shown that 8 day-old mouse embryos cultured for 48 hours in a glufosinate ammonium solution (10 microgram/ml) suffered from significant overall embyronic growth retardation, which was especially present in the craniofacial region (17). Approximately one third of the embryos showed specific defects including hypoplasia of prosencephalon and visceral arches

Similarly, 100% of 9 day-old rat embryos cultures in the same solution of glufosinate ammonium showed malformations and a greatly reduced size of crown-rump length. Ten day-old mice embryos, cultured for 24 hours in a glufosinate solution (60 microgram/ml) showed a high percentage of morphological defects (84.6%) and death in some cases (7.1%).

Given that glufosinate-tolerant GE crops will be blanket sprayed at regular intervals with glufosinate ammonium, herbicide residues will be significant and may contribute to such defects in human embryos.

Bayer Crop Science Pty Ltd has an abysmal record with respect to careful and thorough scientific practices, biosafety and subsequent responsible behaviour. Contamination of US rice crops with an unapproved Bayer GE rice line (LL601 or "Liberty Link") has resulted in cancelled export orders which could cost the US rice industry in excess of $US 1.2 billion. This is the biggest marketing and financial disaster in the history of the US rice industry. An independent economist estimated the total costs to the industry (22).

In August 2006, traces of the uncertified Bayer GE rice were found in US rice supplies. Sixty percent of US rice exports were affected. The contamination was found in rice sent to at least 30 countries. Major importers, including the EU and the Philippines closed their markets to US rice. They remain closed today. Up to US$253 million was lost from food product recalls, and future export losses could reach $445 million (22).

The contamination came from experimental field trials that ended in 2001. Liberty Link has never been grown commercially. Attempting to lessen the damage after the scandal broke, the US government decided to approve the rice strain. However, this was not an effective deterrent and the US rice industry is still reeling (22).

Hundreds of US farmers and European businesses have filed lawsuits against Bayer in attempts to recoup their losses. Punitive or statutory damages that may be awarded against Bayer may double or even treble the final cost of the GE contamination incident.

Bayer’s response to the disaster, which has destroyed the livelihoods of thousands of people, from growers to producers to sellers, was appalling. They claimed that the contamination scandal was probably caused by "an act of God." No independent, long-term, peer-reviewed studies proving that the consumption of transgenic food is safe

There have been no independent, long-term, peer-reviewed studies proving that the ingestion of any transgenic foods is safe for humankind. Nor has the US population – being the principle country releasing untested, unlabelled genetically engineered foods over a period of years - been monitored for any resulting effects of ingesting multiple transgenic foods on a continuous, daily, long-term basis. There has been no independent scientific study to see if there is a link or not between the two- to ten-fold increase in food-borne illnesses in the US (1994 to 1999) and the commercial release of transgenic crops there from the mid 1990s onwards. In Scandinavia, where genetically engineered foods have not been widely allowed in the food chain, the same statistics have remained virtually static. Nor has the US evaluated rates for cancers or other statistically monitored health problems since the introduction of genetically engineered foods.

In summary, PSRG regards genetically engineered (GE) foods as inherently unsafe, with current safety assessments not competent or complete enough to protect from, or even identify, most of the risks.

PSRG supports a zero-tolerance level for genetically engineering organisms in foodstuffs. This is technically achievable.

PSRG supports an Identity Preservation traceability system being in place on all foodstuffs to ensure that labelling accurately reflects the presence or absence of food or food ingredients produced using genetic engineering technology. Mandatory IP traceability would facilitate quality control, the verification of labelling claims, and the possible necessity of withdrawing products should unforeseen adverse effects to human health or the environment occurs. It will also facilitate the monitoring of potential effects that genetically engineered organisms could have on human and animal health and the New Zealand environment.

PSRG supports mandatory, fully detailed, accurate, Country of Origin labelling for all packaged and unpackaged meat, fish, dairy produce, fruit and vegetables, be they in a whole form or as part of an ingredient or additive, or used in the production thereof.

PSRG supports full public disclosure of all information gathered by, or required to be gathered by, government on residues in foods whether they be from pesticides, herbicides or insecticides, heavy metals, industrial chemicals or their by-products, veterinary medicines and any other contaminants.

Such information is crucial in allowing New Zealanders to make informed purchasing decisions, and to meet the basic human rights of New Zealanders to know where food purchases originate.

(This submission has been prepared with the assistance of Dr Elvira Dommisse, BSc (Hons), PhD, a former GE Scientist for DSIR/Crop & Food Research, Lincoln.)

PSRG are unable to present this submission in person.

Signed by the Trustees of Physicians and Scientists for Responsible Genetics